# K011875: Modification to the Tac' Pin

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Sep 6, 2001 after 83 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983121 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993910: Tac' Pin, New Deal, S.A. (2000) Summary page 2.
- K982931: Threaded Fixation Pin, Sgarlato Laboratories, Inc. (1998) Summary page 2.
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220, Syntec Scientific Corp. (1998) Summary page 2.

## Indications for use
The “new” TAC’pin® is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments, in long bones or small bones fractures. Arthrodesis in hand or foot surgery Mono or Bi-cortical osteotomies in the foot or hand Distal or proximal metatarsal or metacarpal osteotomies Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

Source page: https://510kreport.com/device/K011875
Methodology: https://510kreport.com/methodology